There is good news in this year’s Association for Accessible Medicines report on savings from biosimilars, including a 30% increase over the last year in savings attributed to biosimilars. The report also explores the economic, policy and regulatory headwinds that are preventing the industry from generating savings at a level that would have a dramatic effect on the U.S. healthcare system.
In an interview with Washington Editor Steve Usdin on The BioCentury Show, Craig Burton, executive director of AAM’s Biosimilars Council, calls out business practices and government policies that are holding the industry back and discusses the ways a robust biosimilars market could promote biomedical innovation.

View full story: https://www.biocentury.com/article/653459

#biotech #biopharma #pharma #lifescience #biosimilars #politics #policy #law

00:00 - Introduction
03:45 - IRA
13:38 - Humira
20:44 - Biosimilars Pipeline

This is a previously recorded episode of The BioCentury Show from February 22, 2024. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes.

In a wide-ranging conversation with BioCentury, Bob Nelsen, co-founder and managing director of Arch Venture Partners, said he is excited by the potential for AI to “create a language of biology,” is cautious about investing in China given increasing geopolitical tensions, and is convinced that the U.S. healthcare system could do a far better job of delivering on the promise of rapidly progressing science.
Nelsen, who has helped finance and create more than 150 companies, including 47 that have reached valuations exceeding $1 billion, discussed his conviction that focusing on creating transformational medicines, rather than looking for short-term gains, is a key to success in the life sciences.

View full story: https://www.biocentury.com/article/651502

#biotech #pharma #biopharma #TheBioCenturyShow 

0:00 - Introduction
01:59 - The Promise of AI
08:35 - The Inflation Reduction Act
15:38 - China
25:58 - Building Companies Around Big challenges

As Jane Grogan anticipates the unmet needs in patients five years from now, she’s harnessing a wave of interest in targeting B cells as a key driver of an immunology expansion at Biogen. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Grogan, who became EVP and head of research of Biogen in October, discusses how she’s approaching the mission to build diversity and balance the risk in the company’s portfolio, extending further into disease areas beyond neurology.

View full story: https://www.biocentury.com/article/653208

#RandD #DrugDevelopment #neurology #immunology #nephrology #celltherapy #bcells #CD28 #CD38

00:00 - Intro
01:05 – Expanding Research
08:22 – Integrating Hi-Bio
11:30 – Targeting B Cells
16:35 – Growing the Modality Toolbox

As Astellas prepares to launch four products in parallel, Chief Commercial Officer Claus Zieler is balancing the complexity of this multi-faceted enterprise with a simple guiding principle: it has to work at a local level, and that will change with geography, circumstance and time. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Zieler discusses how to factor local differences in patient behavior, payer systems and regulatory environments into a global launch strategy. He also advocates for a seamless integration of R&D and commercial efforts throughout the lifecycle of each product, from early development to loss of exclusivity, and he discusses what small companies need to know when deciding whether to commercialize a therapy on their own.

View full story: https://www.biocentury.com/article/653047

#biotech #biopharma #pharma #lifescience #RandD #deals #licensing #partnerships

00:00 - Intro
01:26 - Focus Area Approach
04:55 - Continuous Teams
09:00 - Building Partnerships
15:24 - Omni Channel Launches
28:40 - Future Pipeline

Ignorance about the path from scientific discovery to approved drugs, high out-of-pocket costs, and a byzantine healthcare system that obscures net prices while inflating list prices have fueled policies that threaten biomedical progress, John O’Brien, CEO of think tank National Pharmaceutical Council, told BioCentury.
In an interview with The BioCentury Show's Steve Usdin, O’Brien, who led efforts to reduce drug prices as an HHS official during the Trump administration, said that whoever wins the White House in November will step into a political atmosphere that is hostile to biopharma companies. While it is difficult to predict what drug pricing policies Trump would pursue if he is re-elected, “Beltway chatter” suggests he would undercut the Inflation Reduction Act’s Medicare drug price negotiation program and attempt to revive international reference pricing proposals, O’Brien said.

View full story: https://www.biocentury.com/article/652931

#biotech #biopharma #pharma #lifescience #politics #policy #law #IRA #healthcare

00:00 - Intro
01:15 - Drug Pricing Policy Overview
09:30 - Inflation Reduction Act
16:20 - A Byzantine Healthcare System

Pediatric cancer drug development is difficult: it requires high levels of safety, involves parents as well as the patients, and has small populations that can make it difficult to achieve the revenues that reward the investment. Squaring that circle, according to Day One Biopharmaceuticals CEO Jeremy Bender, is not impossible, but takes a dedicated strategy that considers both pediatric and adult development paths from the get-go, and pursues them with equal intensity. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Bender discussed the rapid rise of Day One, and how it is building a pipeline and evolving a strategy that allows it to keep pediatric drug development central to its philosophy.

View full story: https://www.biocentury.com/article/652807

#RandD #DrugDevelopment #pediatriccancer #biopharma #pharma #biotech #lifescience

00:00 - Intro
02:25 - Origins & What’s Next
07:57 - Commercialization & Capital
15:28 - Precision Pediatric Strategy
21:00 - First v. Best, ADCs
30:00 - Life as a CEO

The U.S. is experiencing events that are either the first stages of a widespread avian influenza outbreak or a fire drill that will show how well the nation is prepared for an outbreak. The U.S. has not stepped up to meet the challenge, Rick Bright, the former director of BARDA, told BioCentury.
In an interview with The BioCentury Show's Steve Usdin, Bright said there are opportunities for biotech companies to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics. The federal government must provide leadership and funding to unleash industry, but it has acted slowly and hasn’t taken the necessary initiative, Bright said.

View full story: https://www.biocentury.com/article/652676

#biotech #biopharma #pharma #lifescience #politics #policy #law

00:00 - Intro
01:56 - H5N1: State of Play
10:14 - Rebuilding Trust, Vaccines
20:50 - Creating Better Therapeutics
25:34 - BARDA, Barriers to Preparedness
32:50 – Urgent Next Steps

Differentiating on tolerability, raising the bar for efficacy and concentrating small molecule development on indications with minimal IRA exposure are all pieces of Novartis CEO Vasant Narasimhan’s strategy to break into the top pharmas by U.S. sales. Two data readouts this week — one for CML drug Scemblix at ASCO and one for inflammatory disease therapy remibrutinib at the EAACI Congress — may tee up two launches to advance that goal through a strategy focused on prioritizing blockbuster-bound programs. Narasimhan discusses the readouts with Editor in Chief Simone Fishburn on a Special Edition of The BioCentury Show.

View full story: https://www.biocentury.com/article/652562

#biotech #biopharma #pharma #lifescience

00:00 - Intro
01:12 - CML Data
09:34 - Endpoints, Approval Pathway
13:00 – Remibrutinib
24:07 – IRA, Radioligands

“The bar has gotten higher because science has gotten so much better,” John Maraganore says on the latest BioCentury Show. Reflecting on the capital markets and the state of innovation, the founder and former CEO of Alnylam painted a picture of a robust ecosystem fueled by sprawling innovation, where the higher scrutiny by investors will serve the industry well. In a broad-ranging conversation with Editor in Chief Simone Fishburn, Maraganore gives his views on the innovation and funding landscape, geopolitical issues facing the industry and the outlook for the next generation of leaders.

View full story: https://www.biocentury.com/article/652517

#biotech #biopharma #pharma #lifescience #investment #innovation

00:00 Intro
01:50 Innovation Today
09:00 Obesity
12:23 Building, Mentoring Biotechs
16:38 Capital & Competition
24:10 Industry Overhangs

“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about why he hopes and believes the Supreme Court will rule for FDA in litigation over the abortion drug mifepristone; and explained his view that approval of Aduhelm to treat Alzheimer’s disease was one of FDA’s worst decisions

View full story: https://www.biocentury.com/article/652427

#biotech #biopharma #pharma #lifescience #DrugDiscovery

00:00 - Intro 
01:04 - Lowe’s Blog
04:42 - Biosecure Act
09:04 - AI & Drug Discovery
16:46 - FDA, The Abortion Drug, & Aduhelm